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Regulatory barriers to tissue-engineered products
1IsoTis NV, Bilthoven, The Netherlands. eliane.schutte@isotis.com
Medical Device Technology
|May 3, 2002
Abstract:
Autologous tissue-engineering technology uses the body's own regenerative capacity to solve clinical problems. Human cellular- and tissue-based products include an array of medical products for repair, reproduction, replacement and other therapeutic purposes. However, the lack of European Union regulation for these products is putting the future of the technology at risk in Europe.